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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854026
Device Name VEDLAR VENTILATOR (MODIFICATION)
Applicant
Hamilton Medical, Inc.
P.O. Box 30008
Reno,  NV  89520
Applicant Contact ERIC GJERDE
Correspondent
Hamilton Medical, Inc.
P.O. Box 30008
Reno,  NV  89520
Correspondent Contact ERIC GJERDE
Date Received08/26/1985
Decision Date 10/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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